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Thursday, March 04, 2010

Back in early 2009, Celgene was looking rather pleased with the outcome from UK cost-effectiveness watchdog NICE of its multiple myeloma treatment Revlimid.

The drug had won a green light even though the company's "patient access scheme" (as NICE and companies like to refer to cost-sharing deals) really wasn't going to help the UK National Health Service coffers that much. Instead it was NICE's late-2008 end-of-life guidance--a relaxation of the strict cost-per-QALY (quality-adjusted life year) threshold that the agency usually uses to judge whether a drug should be reimbursed or not--that allowed the drug to be waved through.

Not so lucky this time, Celgene. NICE today announced that it would not be recommending myelodysplastic syndrome drug azacitidine (Vidaza) for reimbursement, despite a proposed patient access scheme (almost becoming obligatory for approval these days, it seems) and despite meeting the criteria to be considered under the less stringent end-of-life guidance rules.

Somewhat tantalizingly, Carole Longson, Health Technology Evaluation Center Director at NICE, acknowledged in a statement that the drug could "potentially prolong the life of people with these conditions by around nine months longer than standard treatment," and claimed it was "disappointed" not to be able to recommend it.

We suspect there are poker tactics involved here. If this isn't a call for the company to try harder on its cost-sharing proposals, then what is? Even with the patient-access and end-of-life rules, "the magnitude of additional weight that would need to be assigned to the original QALY for the cost-effectiveness of the drug to fall within the current threshold range would be too great," concluded Longson.

Celgene's already offering a 7% reduction on the drug's acquisition cost, estimated at about £45,000 per patient. But according to NICE's final appraisal determination document, even with this, the most plausible cost-per-QALY would be a whopping £63,000, over double the agency's unofficial threshold.

Unfortunately for Celgene, NICE determined that the cheapest comparator--best supportive care--was also the most appropriate, since it's what's given to the majority of UK patients. This only increased the relative cost of Vidaza; more so than it would have done, for instance, if compared with chemotherapy. What's more, opines Professor Rodney Taylor, deputy chair of the patient support group MDS UK, "they didn't cost [best supportive care] appropriately," underestimating, in his view, the cost of blood transfusions for example.

Celgene plans to appeal the decision, and will argue that the drug fits not only the end-of-life criteria, but also qualifies for various innovation criteria agreed by NICE with the Department of Health designed to increase access to highly novel medicines serving small patient populations. (Read this for more on the review of NICE that led to these proposals). The company is not at this point considering a more aggressive patient-access scheme.

This is the latest in a series of tough decisions emanating from NICE recently; another was its somewhat restrictive policy on second-line anti-TNF use in rheumatoid arthritis patients. These suggest that we were wrong to propose, in the light of the various loopholes that have appeared over the last year or so, that NICE was going soft. The teeth are still there, and sharp, it seems.

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